Luer connection adapters for syringes

ABSTRACT

A connector mountable to a syringe barrel has a proximal barrel-engaging portion, a distal luer fitment portion, and a fluid aperture therethrough. The barrel-engaging portion of the connector includes an axial ledge configured to abut the axial distal edge of a glass syringe barrel. The connector facilitates mounting a luer assembly to the barrel. The luer assembly may be a tip cap, a luer needle assembly, or a luer needle-less assembly, having a complementary luer fitment for connection to the luer fitment portion of the connector. The connector and syringe may further include an immobile, compressible needle seal. The needle seal is adjacent to or engageable with the barrel-engaging portion of the connector.

RELATED APPLICATIONS

This application claims priority benefit of U.S. Application No.61/863,098, filed 7 Aug. 2013, which is incorporated fully herein forall purposes.

FIELD

The embodiments described herein relate to syringes. More particularly,the embodiments provide for luer connections configured to connect tosyringe barrels and provide a luer fitment capable of connecting tofluid lines, selectable needle attachments, and the like, for deliveryof fluids.

BACKGROUND

Today's healthcare practitioners are usually provided with medicaldevices that are ready to use, because the devices are sterilized duringmanufacture. This is particularly true of syringes that are used toadminister parenteral drugs and other medical solutions. A syringetypically includes a plastic barrel having a substantially closed endand an opposite open end. The open end is sealed by a slidable pistonplunger. The closed end of the syringe has a dispensing portcommunicating with a male luer fitment, for dispensing the contents ofthe syringe. The syringe, as manufactured, may be prefilled with aliquid, part-filled with a lyophilized powder, or empty, for example. Aremovable end cover, such as a luer cap is placed over the luer fitmentduring manufacture so as to seal the contents within the barrel.Prefilled syringes are advantageous in avoiding confusion whether a vialis multidose or single dose, or confusion regarding which diluent shouldbe used with a given lyophilized or powder medicament, and may provide asuitable housing for storage and shipping of sensitive pharmaceuticalssuch as biologics. Furthermore, use of prefilled syringes, particularlythose with safety mechanisms, limits health professionals exposure toused syringes, inadvertent needlestick injuries, and possible exposureto infective pathogens or other contaminants.

Because of the increasing demand for prefilled syringes, there is aproportional increasing need syringes that are made or materialsresilient to degradation or interaction with the pharmaceutical or otheragent held within the syringe. Additionally, there are filled-on-demandsubstances that are not compatible with existing plastic syringes. In anattempt to overcome these issues, many syringe manufacturers havereturned to the manufacture of glass syringes or syringes in which atleast the barrel is glass. Current commercial versions of glass syringeshave glass tips that are housed within plastic adapter structures forconnection to syringes or other delivery means. These glass syringeshave several disadvantages: the tips are fragile and may break duringpreparation or use, leading to potentially dangerous sharps; thesyringes leak around imperfect seals between the glass and the adapter;plastic adapter structures may spontaneously disconnect from the glasstip; or the tips may clog due to the narrow nature of the configuredglass tips.

Further, in developing syringes with luer connections, relativelycomplicated luer assemblies have been devised that are often adapted fora particular syringe barrel shape or configuration and cannot be readilymounted to a syringe barrel having a different shape or configuration.This is particularly a problem with glass syringe barrels which aregenerally in short supply, and typically lack the desired shape orconfiguration for mounting a luer assembly. Alternatively, the syringesmay be manufactured with a pre-formed luer assembly, which addssubstantial complexity and cost to the process for manufacture of suchsyringes. Therefore, there is increasing demand for resilient syringeswith adequate connectors for needle and needle-less devices.

SUMMARY

The embodiments of the present invention provide for connectors thatfacilitate mounting of a luer assembly to a pre-formed resilient syringebarrel, such as, for example, a straight, glass barrel. The embodimentsherein provide for a connector that is easily adaptable to a variety ofsyringe barrels and obviates the need to have a particular barrel shapeor configuration for mounting a luer assembly thereto. Aspects of theseembodiments provide for a relatively simplified luer assembly thatcomprises fewer or simpler components, thereby providing a user-friendlyand safe syringe while keeping manufacturing costs to a minimum, orfacilitating mass distribution of syringes. For example, the presentembodiments permit the use of straight glass barrels, rather than glassbarrels with formed distal tips which are significantly more costly tomanufacture. Other aspects provide for efficient delivery of fluidcontents, thereby minimizing waste of fluid contents.

In a one aspect, the embodiments provide a connector configured tocouple with, mount to, or engage with, a syringe barrel, the connectorcomprising a body that includes a barrel-engaging portion, distalportion configured to engage a luer fitment, and an aperture disposedcentrally and axially through the connector. As used in reference to thepresent embodiments, “adapter,” “luer connection adapter,” “lureconnection” may be used interchangeably with “connector.” The connectormay also be configured to couple or mount to, or engage with, a needleassembly or a needle-less assembly. The connector may serve as a needleaperture. In at least one embodiment, the connector (e.g., a luerconnection adapter) also includes a needle seal, which may be mountedwithin the barrel, for example, adjacent and proximal to thebarrel-engaging portion of the connector, and further comprising anaperture positioned to communicate with the connector. In use, theneedle seal may be compressible but substantially immobile. In aparticular embodiment, the needle seal is engaged with a portion of theconnector. Suitably, when the connector is coupled with a needleassembly, a cannula of the needle assembly is received or accommodatedby, or extends through, the needle aperture of the connector.

Another embodiment provides for a syringe barrel comprising theconnector and, optionally, the needle seal. Another embodiment providesfor a syringe comprising the connector situated in a syringe barrel,optionally with the needle seal, and, optionally, a plunger.

An aspect of the embodiments provides a method of assembling all or partof a syringe comprising the novel connector. A further aspect provides amethod of use of the syringe, including the step of delivering fluidcontents of the syringe to a subject, such as a human. The syringe ofthe aforementioned aspects may be a syringe for connection, via luerlock connection, to an intravenous fluid line. A luer lock connectioncan be a conical or tapered connection having a screw-threaded matingconfiguration. The syringe can be a pre-filled syringe, a mixingsyringe, a sequential delivery syringe, or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the invention are described herein withreference to the following drawings wherein:

FIG. 1A is a sectional view of an embodiment of a connector assembly anda removable tip cap; and FIG. 1B is an isometric sectional view theembodiment of FIG. 1A.

FIG. 2A is a sectional view of an embodiment of a connector having aneedle assembly attached thereto, and FIG. 2B is an isometric sectionalview of the embodiment of FIG. 2A

FIG. 3A is a sectional view of an alternative embodiment of a connectorassembly and a removable tip cap; FIG. 3B is an isometric sectional viewof the same embodiment; FIG. 3C is an isometric sectional view of theembodiment of FIG. 3A showing the tip cap removed; and FIG. 3D is anexploded side view of the separate components of the embodiment of FIG.3A.

FIG. 4A to FIG. 4C are isometric sectional views of an embodimentshowing a connector housed in a syringe barrel comprising a collar(FIG.4A), a tip cap (FIG. 4B, and a needle assembly (FIG. 4C).

DETAILED DESCRIPTION

All patents and other publications identified are expressly incorporatedherein by reference for the purpose of describing and disclosing, forexample, the methodologies described in such publications that might beused in connection with the present invention. These publications areprovided solely for their disclosure prior to the filing date of thepresent application. Nothing in this regard should be construed as anadmission that the inventors are not entitled to antedate suchdisclosure by virtue of prior invention or for any other reason. Allstatements as to the date or representation as to the contents of thesedocuments are based on the information available to the applicants anddoes not constitute any admission as to the correctness of the dates orcontents of these documents.

As used herein and in the claims, the singular forms include the pluralreference and vice versa unless clearly indicated otherwise by context.Throughout this specification, unless otherwise indicated, “comprise,”“comprises” and “comprising” are used inclusively rather thanexclusively, so that a stated integer or group of integers may includeone or more other non-stated integers or groups of integers. The term“or” is inclusive unless modified, for example, by “either.” Other thanin the operating examples, or where otherwise indicated, all numbersexpressing quantities of ingredients or reaction conditions used hereinshould be understood as modified in all instances by the term “about.”

Unless otherwise defined, scientific and technical terms used inconnection with the formulations described herein shall have themeanings that are commonly understood by those of ordinary skill in theart. The terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to limit the scope ofthe present invention, which is defined solely by the claims. The termsmale and female may be used interchangeably to describe correspondingcomponents or complementary aspects thereof and are not a limitation toeither particular structure unless context clearly indicates otherwise.

As used herein to describe the relative positions of the components ofthe present embodiments, the terms “axial” or “axially” refer generallyto a longitudinal axis “A” of the barrel of a syringe and plunger inwhich or around components are positioned, although not necessarilysymmetrically there-around. The term “radial” refers generally to adirection perpendicular to axis A. The terms “proximal,” “rear,”“rearward,” “back,” or “backward” refer generally to an axial directionin the direction “P.” The terms “distal,” “front,” “frontward,”“depressed,” or “forward” refer generally to an axial direction in thedirection “D,” toward the dispensing end of the syringe.

“Fluid” refers primarily to liquids, but can also include suspensions ofsolids dispersed in liquids (dispersions, suspensions, colloidalmixtures), emulsions, liposomal compositions, and gasses dissolved in orotherwise present together within liquids inside the fluid-containingportions of syringes.

As used herein, the term “glass” should be understood to include othersimilarly non-reactive materials suitable for use in a pharmaceuticalgrade application that would normally require glass (e.g., Type Iborosilicate glass), including but not limited to certain non-reactivepolymers such as cyclic olefin copolymers (COC) and cyclic olefinpolymers (COP).

The term “plastic” may include both thermoplastic and thermosettingpolymers. Thermoplastic polymers can be re-softened to their originalcondition by heat; thermosetting polymers cannot. As used herein, theterm “plastic” refers primarily to moldable thermoplastic polymers suchas, for example, polyethylene and polypropylene, or an acrylic resin,that also typically contain other ingredients such as curatives,fillers, reinforcing agents, colorants, or plasticizers, etc., and thatcan be formed or molded under heat and pressure. As used herein, theterm “plastic” can include pharmaceutical grade non-reactive polymers orelastomers that are approved for use in applications where they are indirect contact with therapeutic substances, such that the plastics donot interact with the substances contacting the plastic and are notreadily susceptible to leaching or gas migration under ambienttemperature and pressure.

The term “elastomer,” “elastomeric” or “elastomeric material” refersprimarily to cross-linked thermosetting rubbery polymers that are moreeasily deformable than resilient plastics, are approved for use withpharmaceutical grade substances, and are not readily susceptible toleaching or gas migration under ambient temperature and pressure. It isappreciated in the art that particular elastomeric polymers are bettersuited for contact with pharmaceuticals than are some particularplastics, hence the elastomeric material can be a biocompatiblematerial. As used herein, the term “elastomer,” “elastomeric” or“elastomeric material” may also include other biocompatible materials,such as styrenic block copolymers (TPE-s), polyolefin blends (TPE-o),elastomeric alloys (TPE-v or TPV), thermoplastic polyurethanes (TPU),thermoplastic copolyesters, or thermoplastic polyamides, among otherbiocompatible materials which are approved for use with pharmaceuticalgrade substances, and are not readily susceptible to leaching or gasmigration under ambient temperature and pressure.

References to “prefillable” generally refer to syringes comprisingcomponents for filling with a substance prior to dispensing thesubstance for its intended use. More specifically, in the context of thesyringe embodiments, the term “prefillable” refers to a configuration orstate in which a substance may be introduced into the syringe any timeprior to the dispensing by the syringe of the substance(s) for theirintended use (such as delivery into a subject or device either directlyor indirectly). A prefillable syringe thus includes syringes describedherein as prefilled, fill-at-time-of-use, fill-on-demand, ready-to-use,and the like.

References to “pharmaceutical agent,” “pharmaceutically active,”“pharmaceutical,” “drug,” “medicament” “active agent,” “active drug” andthe like, refer in a general sense to substances useful in the medicaland scientific arts as suitable for delivery via a syringe, including,for example, drugs, biologics, diagnostic agents (e.g, dyes or contrastagents) or other substances used for therapeutic, diagnostic, orpreventative (e.g., vaccines), or research purposes. Examplepharmaceutical agents include biologics, vaccines, chemotherapeuticagents, contrast agents, small molecules, immunogens, antigens,interferons, polyclonal antibody preparations, monoclonal antibodies,anesthetics, interfering RNAs, gene vectors, insulins, or combinationsof any of these. “Inactive” substances refer to carriers, excipients,diluents, and the like, which are well-known in the art, although suchsubstances may have beneficial function in the mixed injectable, suchas, for example, adjuvants, isotonic or buffering agents. These activeor inactive substances may also include substances having immediate,delayed or sustained release characteristics.

At least one embodiment provides for a connector comprising a distalportion configured to engage a luer fitment, a proximal syringebarrel-engaging portion comprising an axial ledge configured to abut anaxial distal edge of a glass syringe barrel, and a fluid apertureaxially therethrough.

At least one embodiment provides for syringe assembly comprising a glassbarrel and a distal connector that includes a distal portion configuredto engage a luer fitment, a proximal syringe barrel-engaging portionwith an axial ledge configured to abut the axial distal edge of theglass barrel, and a fluid aperture therethrough. In some embodiments,the connector includes locking means that permanently connect theconnector to a connection, such as a needle assembly. Some embodimentsof the syringe assembly include a needle seal, located proximal to theconnector and having a fluid aperture therethrough, in which the needleseal fluid aperture is configured to align with the connector fluidaperture to form a fluid passage. The needle seal can be constructed ofan elastomeric material or a biocompatible material. The needle seal andconnector may further include means for fixedly engaging with eachother. Some embodiments of the syringe further include a tip cap havinga body comprising a projection configured to engage the distal end ofthe connector fluid aperture and block fluid passage. The needle sealand the tip cap ensure that the drug fluid does not contact anon-compatible material during transportation and storage, i.e., priorto use. In particular embodiments, the projection extends through theconnector at least into the needle seal. The projection can beconstructed of an elastomeric material or a biocompatible material. Theprojection can be contiguous with or a separate piece of the tip cap. Insome embodiments, the syringe includes a distal means for irreversiblyindicating the tampering with, or use of, the connector. In someembodiments, the tip cap includes a means for irreversibly indicatingthe tampering with, or removal of, the tip cap.

At least one embodiment provides for a syringe comprising a glassbarrel, a plunger, and a distal connector comprising a distal portionconfigured to engage a luer fitment; a proximal syringe barrel-engagingportion comprising an axial ledge configured to abut the axial distaledge of the glass barrel; and a fluid aperture therethrough. In someembodiments, this syringe further includes a needle seal, locatedproximal to the connector and having a fluid aperture therethrough, inwhich the needle seal fluid aperture is configured to align with theconnector fluid aperture to form a fluid passage. Some embodiments ofthe syringe further include a tip cap having a body comprising aprojection configured to engage the distal end of the connector fluidaperture and block fluid passage. The needle seal or the projection canbe constructed of an elastomeric material or a biocompatible material.In some embodiments, the plunger includes a means for irreversiblyindicating the tampering with, or use of, the plunger. In someembodiments, the tip cap includes a means for irreversibly indicatingthe tampering with, or removal of, the tip cap.

Another aspect of the present embodiments provides for prefilledsyringes comprising connectors, in which the syringe is prefilled orprefillable with a substance. The substance can be a pharmaceuticalagent. References to “pharmaceutical agent,” refer in a general sense tosubstances useful in the medical and scientific arts as suitable fordelivery via a syringe, including, for example, drugs, biologics,diagnostic agents (e.g, dyes or contrast agents) or other substancesused for therapeutic, diagnostic, or preventative (e.g., vaccines), orresearch purposes. For example, the pharmaceutical agent can be abiologic, a vaccine, a chemotherapeutic agent, a contrast agent, a smallmolecule, an immunogen, an antigen, an interferon, a polyclonal antibodypreparation, a monoclonal antibody, an anesthetic, an interfering RNA, agene vector, an insulin, or a combination of any of these.

Referring to FIG. 1, this figure shows an embodiment of a connectorcomprising a distal portion configured to engage a luer fitment and aproximal syringe barrel-engaging portion, which connector includes afluid aperture axially therethrough. More specifically, luer connectionadapter 50 disposed at the distal end of barrel 10 having a distalconnection end 15 and interior wall 18. As shown in FIG. 1, barrel 10 issubstantially cylindrical in shape, but the connectors described hereincan be adapted for a variety of barrel shapes. The barrel can be formedof glass, but other resilient plastics or polymers may be used inmanufacturing the barrel. As shown in FIG. 1, at distal connection end15 of barrel 10 is mounted barrel connector 50. Connector 50 includes anaxial ledge or shelf structure 55 configured to abut the distal barrelend 15, thus creating a connection point at which the abutting surfacescan be glued or otherwise permanently affixed to each other. Forexample, adhesive can be used to permanently connect the barrel and theadapter materials, such as glass and plastic, respectively. The adhesiveis typically stable under sterilization and procedures, and storage anduse conditions. The adhesive may be a curable adhesive, such as a heat-,time-, water- or UV-light-cured adhesive. The adhesive may be clear orcolorless. Such adhesives are well known in the art. Alternatively, aconnector can be pressure-connected into the barrel, for example by adesign of portion of the adapter that sits within the barrel, such as53, configured to press outwardly and immobily against the interiorsurface 18 of barrel 10. Barrel 10 further comprises inside wall 18which, together with needle seal 40 and typical proximal syringecomponents such as a plunger, defines fluid space 12 inside barrel 10.

With further reference to FIG. 1 and FIG. 2, connector 50 includes aluer connection portion comprising a distal luer lock connection havinga tapered/conical aspect 56 and a screw-threaded mating structure 57.Connector 50 includes luer fitment 56 that extends distally from the endof syringe barrel 10. Luer fitment 56 is generally tubular and formedwith a central, axial bore or fluid passageway extending axiallythere-through. The outside surface of the male luer fitment is taperedalong the extending length to provide a surface sealingly mateable withthe inner tapered surface of a female luer connector, therebyestablishing a seat for and seal with a female luer hub. Luer adapter 50further includes screw-thread 57 for further connecting to a luerconnection, needle assembly, or other structure. For example, the femaleluer connector may be in the hub of a sharp needle assembly shown inFIG. 2, or as part of a fluid line, such as an intravenous fluid line,connection. Notably, adapter 50 has a center bore or central fluidpassageway 54, which may be dimensioned to meet the necessary or desiredrequirements of the particular fluid or delivery mechanism.

Additionally, as shown in FIG. 1 and FIG. 2, the connector and barrelmay further comprise an immobile, compressible elastomeric needle seal40. The elastomeric needle seal is proximally adjacent to or engageablewith the barrel-engaging portion of the adapter. More specifically, inthe embodiments of FIG. 1 and FIG. 2, needle seal 40 sits within barrel10 against interior wall 18, and proximal surface 51 of luer adapter 50meets distal surface 49 of elastomeric needle seal 40. Needle seal 40 isconfigured with at least one radial, circumferential ring or rib 43 thatbears against barrel interior wall 18 to form a liquid-tight seal.Needle seal 40 further comprises passage 44, configured to align withconnector aperture 54. Needle seal 40 can be made of an elastomeric,rubber-based polymer that is particularly resilient to degradation orinteraction with chemicals, pharmaceuticals or liquids in general, ormay include such materials at proximal surface 41. In at least oneembodiment, use of the elastomeric material of the needle seal is moredesirable for contact with the contents of a syringe, particularly inprefillable syringes storage conditions, than are typical plastics usedfor syringes or molded syringe parts. Additionally, the connector caninclude tamper-resistant or tamper-evident components.

In the embodiment depicted in FIG. 1, connector 50 includes luerconnection portion 57 and barrel-interior portion 53, a barrel-engagingportion 55 and aperture 54 there-through. The connector shelf or ledge55 facilitates mounting the connector to distal barrel end 15. As shownin FIG. 1, the connector assembly may include tip cap 60 with proximalsurface 61 that abuts distal surface 59 of connector 50; which tip capincludes a female luer fitment 68 for receiving male luer fitment 56,and screw thread 67 complementary to screw thread 57 of the distal luerfitment portion of connector 50. Tip cap 60 further includes elastomericstem 64 that passes through channel 54 and needle seal channel 44. Stem64 can be made integral to tip cap 60, or can be a separate component ofthe tip cap (see FIG. 3). In the configuration shown in FIG. 1, when thetip cap is in place, the contents of a prefilled syringe do not contactthe plastic of the connector during storage. Instead, such contentscontact only the elastomeric materials of needle seal 40 and theproximal end of stem 64, which can be formed from biocompatiblematerials. Tip cap 60 can be placed on luer connection adapter 50 beforesterilization processes or under aseptic conditions such that itmaintains sterility of the luer connector and syringe contents. This isparticularly advantageous for use in prefilled syringes.

As shown in FIG. 2, a selectable needle assembly may be utilized andconnected to the syringe to facilitate delivery to a user via injection.The needle assembly can be any appropriate needle or needle assembly,without limitation. In the embodiment of FIG. 2, luer connection adapter50 may house a luer needle assembly having needle hub 70, whereinproximal end 71 of needle hub 70 abuts distal end 59 of the luerconnection portion of connector 50. Needle hub 70 houses a first luerfitment 76 and screw thread 77 for connection to the corresponding luerfitment 56 and complementary screw thread 57 of adapter 50. Needle 78 isheld in channel 73A of needle-over-mold 73, the distal end of theneedle-over-mold 79 is held in channel 70A of needle hub 70. In theembodiment of FIG. 2, needle-over-mold 73 has proximal end 72, throughwhich passes channel 73A. In this fashion, fluid communication ispossible between and through the interior chamber 12 of barrel 10 andfluid channel 78A of needle 78. A variety of needle assemblies arecompatible with the luer connection adapters described herein, such as,for example, needle assemblies described in U.S. Pat. No. 8,167,837.

Another embodiment of a connector as housed in a syringe includes adistal means for irreversibly indicating the tampering with, or use of,the connector. More specifically, for example, FIG. 3 shows connector150 includes ledge 155, which abuts and is adhered to distal barrelconnection point 15. A proximal portion 153 of connector 150 extendsinto barrel 10. Connector 150 also includes luer fitment 156 and athread-screw configuration 157 for attachment to a tip cap, needleassembly, needle-less assembly (e.g., an i.v. luer line), and the like.In this embodiment, needle seal 140 is positioned within barrel 10,abutting its interior wall 18 and held in place by pressure exertedagainst surface 18 by ribs 143, or by interaction between protrusion 142and window 158. Needle seal 140 further includes a locking meanscomprising protrusion or nub 142 configured to insert into or through anopening or window 158 in adapter 150, such that protrusion 142 andwindow 158 lock needle seal 140 and connector 150 in an engagedposition. Needle seal 140 includes aperture 144, and distal end 149 thatextends axially and distally within the proximal end of connector 150,received by complementary surface 151.

The embodiment of FIG. 3 further comprises tamper-evident tip cap 160.Tip cap 160 includes proximal portion 161 that abuts distal portion 159of connector 150. Scored line 163 extends circumferentially around andpartially, but not fully, through tip cap 160 distal to proximal portion161, such that attempting to remove the cap provides biofeedback in theform of tangible resistance in attempting to remove the cap, a feelingof quick release when score line 163 is broken fully, and a slight noiselike a snap or pop when score line163 breaks and separates proximalportion 161 from the remainder of the cap structure. Therefore, if anoperator finds that tip cap 160 is removed easily without resistance ornoise, the operator may assume that the tip cap has been breached, andthe device should not be used without consideration that the syringecontents may have been contaminated. Additionally, as shown in FIG. 3C,proximal portion 161 remains attached to connector 150, such as by tooth162, even after the distal portion of cap 160 has been removed;providing visual feedback that the syringe may have been compromised ifnot used. In the embodiment of FIG. 3, tip cap 160 is made of resilientplastic to facilitate the tamper-evident features, and thus stem 164 isa separate elastomeric, drug-compatible stem that is seated in and heldin place by tip cap cavity 166. Stem 164 may further compriseprotrusions 165, shown particularly in FIG. 3D, to secure stem 164within tip cap 160. Alternative mechanisms can be adapted for use withthe connectors in relation to tamper-resistant devices, but in certainembodiments may lack the biofeedback (tactile) associated with breakingof tamper-resistant or tamper-evident seals.

FIG. 4A to FIG. 4C exemplify syringes that include some embodiments ofconnectors described herein. FIG. 4A shows a syringe assembly comprisinga glass barrel; and a distal connector comprising a distal portionconfigured to engage a luer fitment and a proximal syringebarrel-engaging portion comprising an axial ledge configured to abut theaxial distal edge of the glass barrel, and having a fluid aperturetherethrough. More specifically, FIG. 4A shows a syringe that has barrel10 with cap 13, in which interior wall 18 is suitable for contact with asubstance housed in void 12. The embodiment of FIG. 4A further includesneedle seal 40, having aperture 44 in fluid communication with aperture54 of connector 50. Connector 50 further includes male luer fitment 56and screw-threads 57 for connection to a needleless access device (suchas an intravenous line), or a needle assembly, and the like. Connector50 is connected at ledge 55 to the distal connection end 15 of barrel10. Syringes comprising plungers can include, for example, standardplungers known in the art.

As shown in FIG. 4B and FIG. 4C, The syringe can further include aneedle seal, located proximal to the connector, having a fluid aperturetherethrough, wherein the needle seal fluid aperture is configured toalign with the connector fluid aperture to form a fluid passage. Asshown in FIG. 4B, the syringe may be capped at the distal end by a tipcap. As described herein, an elastomeric tip cap, for example, may beused for this purpose though plastic tip caps and tip caps of othermaterials may also be utilized. If the syringe is to be utilized with aneedle assembly, a needle assembly may be contained in a needle cap.FIG. 4C shows a syringe with the needle assembly connected via theconnector 50. A needle cap, such as needle cap 75, containing the needleassembly may be utilized to safely connect the needle assembly to thesyringe (i.e., without exposure to the needle).

The embodiments of the present invention may further utilize additionalcomponents to enhance the use of the syringe, such as tamper-resistanceaspects to prevent tampering of the syringe. These tamper-resistanceaspects deter or prevent an unauthorized user from, for example,removing the plunger rod, or provide evidence of tampering such that anunauthorized user will be discouraged from compromising the syringe.These tamper-resistance aspects could be located along the plunger rod,plunger seal, or the barrel flange, collar, or release ring. Thesetamper-resistance aspects could be axially positioned or longitudinallyoriented, or in a number of other known configurations.

Each of the embodiments described herein may be used alone or incombination with one or more other embodiments in a syringe. Throughoutthe specification, the aim has been to describe the preferredembodiments of the invention without limiting the invention to any oneembodiment or specific collection of features. Various changes andmodifications may be made to the embodiments described and illustratedwithout departing from the present invention. The disclosure of eachpatent and scientific document, computer program and algorithm referredto in this specification is incorporated by reference in its entirety.

What is claimed is:
 1. A connector comprising a distal portionconfigured to engage a luer fitment; a proximal syringe barrel-engagingportion comprising an axial ledge configured to abut an axial distaledge of a glass syringe barrel; and a fluid aperture axiallytherethrough.
 2. A syringe assembly comprising a glass barrel; and adistal connector comprising a distal portion configured to engage a luerfitment, a proximal syringe barrel-engaging portion comprising an axialledge configured to abut the axial distal edge of the glass barrel, anda fluid aperture therethrough.
 3. The syringe assembly of claim 2,further comprising a needle seal, located proximal to the connector,having a fluid aperture therethrough, wherein the needle seal fluidaperture is configured to align with the connector fluid aperture toform a fluid passage.
 4. The syringe assembly of claim 3, wherein theneedle seal is constructed of an elastomeric material or a biocompatiblematerial.
 5. The syringe assembly of claim 2, further comprising a tipcap having a body comprising a projection configured to engage thedistal end of the connector fluid aperture and block fluid passage. 6.The syringe assembly of claim 5, wherein the projection is constructedof an elastomeric material or a biocompatible material.
 7. The syringeassembly of claim 2, further comprising a distal means for irreversiblyindicating the tampering with, or use of, the connector.
 8. A syringecomprising a glass barrel; a plunger; and a distal connector comprisinga distal portion configured to engage a luer fitment, a proximal syringebarrel-engaging portion comprising an axial ledge configured to abut theaxial distal edge of the glass barrel, and a fluid aperturetherethrough.
 9. The syringe of claim 8, further comprising a needleseal located proximal to the connector and having a fluid aperturetherethrough, wherein the needle seal fluid aperture is configured toalign with the connector fluid aperture to form a fluid passage.
 10. Thesyringe assembly of claim 9 wherein the needle seal is constructed of anelastomeric material or a biocompatible material.
 11. The syringe ofclaim 8, further comprising a tip cap having a body comprising aprojection configured to engage the distal end of the connector fluidaperture and block fluid passage.
 12. The syringe assembly of claim 11wherein the projection is constructed of an elastomeric material or abiocompatible material.
 13. The syringe of claim 8 wherein the plungercomprises a means for irreversibly indicating the tampering with, or useof, the plunger.
 14. The syringe of claim 8 wherein the syringe isprefilled with a substance.
 15. The syringe of claim 14 wherein thesubstance comprises a pharmaceutical agent.
 16. The syringe of claim 15wherein the pharmaceutical agent is selected from the group consistingof a biologic, a vaccine, a chemotherapeutic agent, a contrast agent, asmall molecule, an immunogen, an antigen, an interferon, a polyclonalantibody preparation, a monoclonal antibody, an anesthetic, aninterfering RNA, a gene vector, an insulin, and a combination of any ofthese.